Drugs / TMB-380
last change Dec 2025 re-read 3 minutes ago

TMB-380

also known as VRC-07-523LS

Monoclonal antibody

Developed for
HIV infectious disease
Investigated by
TaiMed Biologics Inc.

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial · 1 met primary
Phase 1/2 NCT05275998 Jul 2022 → Nov 2024 HIV infectious disease TaiMed Biologics Inc. Completed Met primary
Phase 21 trial
Phase 2 NCT07215468 Dec 2025 → Aug 2027 expected HIV infectious disease TaiMed Biologics Inc. Active not recruiting No outcome recorded

Press releases naming this drug 11 releases

DateIssuerRelease
2025-12-17 TaiMed Biologics Inc. TaiMed Biologics (4147) Announces First-Patient-In for Its World's First Long-Acting Dual Antibody HIV Therapy TMB-365/TMB-380 Phase 2b Trial, Marking a Key Acceleration Milestone in Global Long-Actin taimedbiologics.com ↗
2025-11-25 TaiMed Biologics Inc. TaiMed Biologics (4147) Announces Its World-First Long-Acting Dual Antibody HIV Therapy TMB-365/TMB-380 Wins the 22nd National Innovation Award taimedbiologics.com ↗
2025-03-12 TaiMed Biologics Inc. TaiMed Biologics to Present Late-Breaking Phase IIa Data at CROI 2025 on Long-Acting TMB-365/TMB-380 Regimen for HIV Maintenance Therapy. taimedbiologics.com ↗
2025-01-21 TaiMed Biologics Inc. TaiMed Announces Phase 2a Clinical Study Results of Long-Acting TMB-365/TMB-380 Combination Therapy for HIV Have Been Accepted to Present at CROI 2025 Annual Conference taimedbiologics.com ↗
2024-11-25 TaiMed Biologics Inc. TaiMed Biologics Announces the Completion of Last Participant Last Visit in Phase 2a Clinical Study of Long-Acting TMB-365 and TMB-380 Combination Therapy for HIV taimedbiologics.com ↗
2024-10-26 TaiMed Biologics Inc. TaiMed Biologics Announces the Completion of Last Participant Treatment Session in Phase 2a Clinical Study of Long-Acting TMB-365 and TMB-380 Combination Therapy for HIV taimedbiologics.com ↗
2024-08-30 TaiMed Biologics Inc. TaiMed Biologics Announces Last Patient Completed Dosing in Phase 2a Study of Long-Acting TMB-365 and TMB-380 Combination Therapy for HIV Therapy taimedbiologics.com ↗
2024-05-10 TaiMed Biologics Inc. TaiMed Announces Enrollment of the last Patient in Phase 2a Study of the Long-Acting TMB-365/TMB-380 mAb Combination for the Bi-monthly Injection Maintenance HIV Therapy taimedbiologics.com ↗
2024-03-22 TaiMed Biologics Inc. The Company Announces Enrollment of First Patient in Phase 2a Clinical Study of the Long-Acting TMB-365/TMB-380 mAb Combination for the Bi-monthly Maintenance HIV Therapy taimedbiologics.com ↗
2024-02-13 TaiMed Biologics Inc. The US FDA grants Fast Track Designation to TMB-365/TMB-380 Long-Acting Combination therapy for HIV Infection taimedbiologics.com ↗
2023-11-16 TaiMed Biologics Inc. The announcement that TaiMed has initiated Phase 2 Clinical Study of Bi-monthly Dosing of TMB-365/TMB-380 Combination for the Treatment of HIV Infection taimedbiologics.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as TMB-380 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07215468 ↗
1

NCT05275998 ↗

Known as VRC-07-523LS “TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV.” NCT05275998 ↗
1

“VRC07-523LS” NCT07215468 ↗

Action Inhibit “Both interfere with HIV entry.” NCT07215468 ↗
Modality Monoclonal antibody “TMB-380, aka VRC-07-523LS is a monoclonal antibody” NCT05275998 ↗
Route Intravenous “to be given intravenously” NCT07215468 ↗